While the opioid crisis has been dominating national headlines for months, denoted as one of the worst public health crises in the US’s history, children born addicted to opiates are hardly discussed. If a woman uses prescription painkillers while their child is in utero, the child has a substantial chance of developing neonatal abstinence syndrome. This is a generic term for those born addicted to drugs. Common symptoms include physical and neurological deformities, as well as long-term developmental problems.

Although it is impossible to establish exactly how many children are born in the United States with neonatal abstinence syndrome due to different reporting guidelines from state to state, it cannot be disputed that the number has been increasing throughout the last two decades. In 2013, more than three times as many kids were being treated for the condition than in 1999, as the opioid epidemic stated to sweep the country.

Litigators blame the practices of large pharmaceutical corporations and distributors for the increasing rate of neonatal abstinence syndrome and the nationwide opioid epidemic at large. Although the mothers used the drugs themselves, they were targets of predatory marketing practices, according to several lawsuits filed by state Attorney General offices around the country. Opioid distributors and manufacturers did not adequately tell potential users about the addictive nature of the medications. This, in part, led to some mothers giving birth to babies addicted to drugs. Some of these corporations include Purdue Pharma and Abbott Laboratories. Claims against corporate giants, such as these, have been filed in 8 states thus far.

Medical costs to care of neonatal abstinence syndrome is astronomical. Medical professionals estimate that it can cost an average of $260,000 in the first year alone. This costs only increases as the child gets older. They may start to develop psychological or social problems, which may require counseling and medication. Having a fund to help these children dramatically offsets the cost, especially considering the fact that the mothers were victims of unethical marketing practices.

For more information, as well as stories concerning individual children born addicted to opioids, read the cleveland.com article [HERE].

 

Pharmaceutical giant AbbVie was threatened by the FDA in December, 2017 for not properly handling complaints that its drugs had been the cause of several deaths that had not been reported to the agency. The FDA had conducted an inspection of AbbVie’s main manufacturing plant in Chicago earlier in 2017, where they learned of five deaths tracible to the company’s best-selling drugs. Eight to eleven more deaths per drug can now be attributed to AbbVie’s top sellers, plus the five that the FDA was already aware of, according to the Form 483 report obtained by STAT (Read their article about it [HERE]). The drugs under scrutiny are Humira, a drug used to treat arthritis, and Venclexta, which is used to treat chronic leukemia. Venclexta is usually used in conjunction with Rituxan as a supplemental form of therapy.

The company is criticized for not investigating these claims thoroughly enough, and this is mirrored through the conduct at the Chicago manufacturing plant. Many of the practices taking place in the factory were not up to the FDA’s standard. For example, AbbVie employees failed to test reserve samples of their drugs to see if the active ingredients were still functioning properly. They were also scrutinized for having no documentation of investigating the death complaints that the plant had received.

The FDA termed AbbVie’s handling of the complaints “inadequate.” A spokesperson for the drug company stated “[they] investigated all complaints where a death has occurred during the use of our products.” This, however, is clearly contradictory to the FDA’s reporting.

Humira is AbbVie’s best-selling drug; it made the company $18.5 billion of the company’s total revenue of $28.2 billion in 2017(roughly 65%). The arthritis medication is only slated to go up in consumption over the next several years.

Despite the malfeasances of AbbVie, the FDA has not formally sanctioned them, and it is unknown if they plan to at this time.

San Diego-based Acadia Pharmaceuticals released their first and only drug, Nuplazid, to the market in June of 2016. Coined a “breakthrough therapy” at the time, the medication sought to relieve Parkinson’s disease patients of hallucinations and psychosis. Nuplazid was approved by the FDA through a special expedition process, which required fewer clinical trials. In fact, the drug was approved after only a six-week test of 200 patients. The FDA committee who approved the drug was swayed by testimonies from people whose loved ones were suffering from horrible hallucinations and distorted realities.

However, since Nuplazid was not properly tested, the panel had no way of knowing that the drug could be dangerous. Three of the studies presented to the FDA showed that the drug was not effective at treating what it was intended to.

Nevertheless, it went to market, where vulnerable patients soon found this out about unknown side effects. These included insomnia, vomiting, falling, and other dangerous complications.

Many doctors later contended that it worsened their patients’ conditions.

Worst of all, more than 700 patients have died since the drug was approved by the FDA. Some have opined that patients are twice as likely to die from Nuplazid than a placebo.

In the time since their drug’s approval, Acadia has made hundreds of millions of dollars. They have fired back at their critics, giving a number of rationales for Nuplazid’s unusually high amount of deaths.

Parkinson’s patients who do suffer from psychosis are, generally speaking, in the developed, most-severe stages of the disease. This means that they are at a higher chance of death as is. Additionally, these patients are suffering from other aliments associated with the disease and are taking other drugs with Nuplazid.

This may raise the mortality rate and complicate finding the true cause of death. This being said, professionals are rightfully concerned.

Thomas Moore, a senior scientist at the Institute for Safe Medical Practices, stated that the drug “might do more harm than good.”

CNN broke the story about Nuplazid’s high number of deaths. Read it [HERE].

opiate abuse

Just within the past several months, new and staggering statistics have surfaced that really place into perspective the overall scope and devastation of the opioid epidemic that is currently ravaging just about each and every community in the country.

To begin with the Centers for Disease Control issued their annual Vital Signs report that details, among other things, the number of ER visits that were reported to be associated with opioid abuse.  The report concludes just over a 30% increase in ER visits from July 2016 to September 2017.  All indicators show the epidemic getting far worse than originally anticipated.  Read the vital signs report here.

Next the US Surgeon General, just this past month, made an unprecedented announcement advising in essence the need to have Narcan, the opiate-reversing agent, “within reach” and to know how to use it.  His statement read:

I, Surgeon General of the United States Public Health Service, VADM Jerome Adams, am emphasizing the importance of the overdose-reversing drug naloxone. For patients currently taking high doses of opioids as prescribed for pain, individuals misusing prescription opioids, individuals using illicit opioids such as heroin or fentanyl, health care practitioners, family and friends of people who have an opioid use disorder, and community members who come into contact with people at risk for opioid overdose, knowing how to use naloxone and keeping it within reach can save a life.

BE PREPARED. GET NALOXONE. SAVE A LIFE.

See more about the Surgeon General’s alert here.

Finally, counties, municipalities and other third parties continue to file lawsuits in Federal Court seeking to hold both manufacturers and distributors of opiates responsible.

With legal representation for said counties and municipalities across the country on a contingency-fee basis, there is zero risk and zero reason why counties and municipalities across the country should not be seeking redress and contributing to the fight to end America’s greatest public health crisis.

 

The Food and Drug Administration (FDA) distributed a warning letter to physicians concerning the risks of using Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS) on March 18th, 2017. The BVS is a stent placed into one’s coronary artery to widen it and increase blood flow. First, it is placed on a catheter over a balloon, which is inserted into one’s artery through their groin or arm. The balloon fills with air, which, in turn, widens the stent and, by extension, the artery to the desired diameter. The balloon and the catheter are removed, leaving the stent in place. It dissolves after three years. BVS is made of various types of polymers and is used often in coronary bypass surgeries.

Interim five-year clinical study results show that the BVS causes a disproportionate amount of major cardiac events (such as heart failure) and scaffold thrombosis–clotting in the artery–after merely three years. Clotting was found to be over three times higher in patients implanted with the BVS than with the metallic XIENCE drug-eluting stent, which has been approved wholeheartedly by the FDA, does not get absorbed into one’s body, and, coincidentally, is also manufactured by Abbott. XIENCE is implemented in much the same way as the BVS. 13.4% of patients treated with the BVS experienced a major cardiac event three years after their procedure, versus 10.4% of those treated with the XIENCE stent. Other studies show that the BVS fails more often due to suboptimal implantation [READ ABOUT IT HERE]. The clinical trials will persist for the total five years to show the long-term effects of BVS implantation.

Presumably as a result of the startling findings, Abbott has canceled all global sales of the BVS as of September 2017, citing “low commercial sales”. The FDA relayed this news to physicians through another, updated letter, and they recommends the following for doctors who still plan on using their leftover BVSs (These standards are unchanged from their March letter to physicians.):

  • Follow the instructions for target heart vessel selection (e.g., avoiding BVS use in small heart vessels) and optimal device implantation that are included in the BVS physician labeling.
  • Advise patients experiencing any new cardiac symptoms such as irregular heartbeats, chest pain, or shortness of breath to seek clinical care. For more information about risks associated with the BVS, refer to the BVS physician labeling.
  • Advise BVS patients to follow the recommendations for dual antiplatelet therapy (DAPT) prescribed by their health care providers.
  • Report any adverse events related to the BVS that come to your attention. If you suspect a problem with the BVS, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities

Sources:

https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm582728.htm?elqTrackId=5aefb2049a054a1097921600ec4febe4&elq=0982deb115a444c0aa5e26618cc8e735&elqaid=1130&elqat=1&elqCampaignId=643

file:///Users/garrettdowell/Downloads/absorb-bioresorbable-scaffold-dissolving-stent%20(1).html

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm509951.htm

Last Month, the California Supreme Court issued a controversial ruling that will allow drug manufacturers to be held liable for generic versions of the same drug manufactured by another company, even if they have sold the rights to the drug since. This runs contrary to a 2011 US Supreme Court decision, which states that generic drug companies cannot be sued for not properly labeling their products because they must use the same label as the brand-name drug. This ruling essentially stated that anyone negatively affected by a generic drug’s improper labeling could not pursue a legal remedy. Since generic drugs are much cheaper than their brand-name counterparts, the decision seemed to disenfranchise low-income users, especially minorities.

In 2007, a pregnant woman with twins, who is unnamed in the lawsuit, was prescribed the generic version of the drug Terbutaline in order to prevent premature labor. Although Terbutaline is an asthma medication, it has been used “off-label” in order to prevent premature births. She claims that it caused the two children to suffer brain injuries that led to developmental problems, including autism.

Terbutaline was sold by the pharmaceutical company, Novartis, under the name Brethine until it sold the rights to the drug in 2001. Studies from as far back as the 1970s have shown that Terbutaline should not be used by pregnant women, but the Plaintiff’s alleged that Novartis shucked all responsibility for the children’s injuries during the trial by stating that it could do nothing about the warnings on the generic-product’s label.

In a 4-3 decision by the court, Associate Justice Mariano-Florentino Cuellar stated that the federal regulations in play made it “foreseeable” that the former manufacturer, which in this case is Novartis, would not update their former drug’s warning label because it would not be strictly in their financial interests.

Currently, generic-drug’s labels must only match the brand-name’s. The court’s decision further states that the brand-name manufacturer is still liable for discrepancies between its label and the generic’s, even if the brand-name drug has stopped being manufactured. Generic medication manufacturers cannot change the warning labels on the drugs they produce without approval from either the FDA or current generic manufacturer. The generic-drug manufacturer, however, is still liable for injuries if they purposefully change the label from that of the brand-name counterpart, if there is an issue in the manufacturing process, and if the generic manufacturer suggests a use different from that of its FDA approved functions.

This ruling will likely have large implications for the pharmaceutical industry since the ruling was so close, and it deviated from decades of precedent. It is possible that if other state courts rule with the same mindset as the California Supreme Courts, they will pressure the US Supreme Court into reviewing the existing federal regulations.

No matter what the future holds, this is a big win for California consumers! Read the entire opinion of the court courtesy of Stanford Law School [HERE].

The Food and Drug Administration (FDA) has declared that those without a gallbladder should not use the drug, Viberzi. The medication is used to treat Irritable Bowel Syndrome (IBS) with diarrhea. IBS is essentially the contracting of the large intestine, which causes a number of symptoms, such as cramping, pain, and gas, among others. Millions of people suffer from IBS in the United States, but its underlying cause is unknown. Viberzi treats IBS by lowering the number of these contractions, which in turn relives symptoms and improves stool consistency.

However, instead of easing the symptoms of IBS in those without a gallbladder, Viberzi has potentially dangerous side effects. The FDA’s interest in the drug peaked when two gallbladder-less patients died from taking the medication. They died from different, yet interrelated causes. One of the two was afflicted with pancreatitis, or inflammation of the pancreas. The pancreas is an organ that produces hormones in order to help break down sugars going through the digestive system, and it is located proximate to the gallbladder. Coincidentally, those who were at high risk of developing pancreatitis were excluded from clinical trials.

The second of the two patients who died was stricken with spasms from their Sphincter of Oddi (Oddi) and died from complications. Oddi is a muscular valve that connects the duodenum to both the gallbladder and the pancreas and controls the flow of gastric juices and hormones between the two sections. During clinical trials, 8 cases of Oddi contractions were reported, and they were all in patients who did not have gallbladders. It is thought that the contractions of Oddi are the cause of pancreatitis, in this case. Patients who suffered from this were seemingly at a higher risk of developing the inflammation.

Pancreatitis is a common complication Viberzi users face, with 120 cases or deaths reported to the FDA. 118 cases of pancreatitis were reported to the FDA as of February 2017, in addition to the two aforementioned deaths. Of those 120, 68 reported “gallbladder status”, and of those 68, 56 did not have a gallbladder, which shows a strong correlation. Disturbingly, symptoms of pancreatitis, such as stomach pain and vomiting, developed in patients after only a dose or two of Viberzi.

Despite the fact that Viberzi’s label suggests patients without gallbladders should not take the drug, this idea seemingly was alleged to have not been placed at the forefront by its manufacturer, Allergen. Most patients just took a smaller dosage (75mg).

The FDA is working to address all safety concerns.

Actemra is a drug used to treat rheumatoid arthritis, which affects 1.5 million Americans. It can be taken via injection or intravenously. With 760,000 patients worldwide, one would expect the drug to be safe; however, post-clinical studies have found that Actemra can lead to the following noxious side effects:

  • Heart attack
  • Heart failure
  • Lung Complications
  • Death

Actemra is a product of Roche Holding AG and its subsidiary Genentech. They made $1.6 billion off of Actemra in 2016.

The side effects in and of themselves are not usual for an arthritis drug such as this, although some appear at a higher rate. What is alarming is that none of these side effects are listed on the drug’s warning label.

Actemra was approved for general use in 2010, but as reported by STAT, the long-term repercussions of use were not properly studied. These lethal issues came into the public eye in a variety of ways. In one instance, 13,500 cases of the aforementioned effects were reported to Advera Health Analytics through their online initiative, the FDA Adverse Effects Reporting System (FAERS). This is meant to track developments that were not discovered during clinical trials. It found that Actemra patients suffered similar side effects than those taking Humira and other arteritis medications, but many of those were not currently on the drug’s label.

That being said, Actemra may cause cardiovascular disease more than its competitors, as shown by recent studies, but still does not warn patients at all about such potential risk.  Similarly, the rare disease, Pancreatitis, or inflation of the pancreas, appeared in many Actemra patients due to the drug increasing the user’s lipid count, according to post-clinical studies.

Despite the newly discovered facts, the FDA is having a hard time getting the warnings added to the label. This is because they require more evidence than is presented in these studies.

The story of Actemra is analogous to another arteritis drug, Vioxx, which was pulled from the market. Both of the drugs had long-term side effects that were not properly studied during trials and ended with many people getting hurt from those they did not know even existed. Other arteritis drugs have had their effects extensively studied, like Humira, and they appear on its label.

It is important to note that these known cases were either reported to the FDA or an outside source, like FAERS. There are likely many more, different complications that have never been reported, and the ones mentioned may occur at greater rates.

 

Abbvie Pharmaceuticals was ordered to pay out $150 million by a federal court in Illinois for misrepresenting their drug, AndroGel. The medication is meant to treat low testosterone (Low-T) in middle age and older men.

The jury found that Abbvie created a false narrative around the condition, going as far as essentially making it up, in order to profit off of the ignorance of their customers. However, the company was not found guilty of causing adverse effects, like the heart attack the plaintiff had while taking to drug. They verdict was made up of only punitive damages and not compensatory damages.

AndroGel and other Low-T drugs can be taken in many forms, including:

  • Gel (as the name would imply)
  • Injection
  • Pellets
  • Patches

AndroGel is only approved for treating hypogonadism, which is condition that causes the body to produce lower-than-normal levels of testosterone. Over the years, it has made Low-T synonymous with aging, meaning any man can potentially take these drugs. In this sense, the condition being treated is made up in most situations.

Abbvie has done this in several ways. One way is simply having doctors not check the patient for hypogonadism; they may not even be aware of the requirement. Hypogonadism can be found through a routine blood test. ¼ of all AndroGel users never had the test done, and ½ of those taking the drug were not diagnosed with it in the first place.

Another example would be Abbvie’s website, which contains a self-diagnosis test with overly broad questions, like “Are you tired?” or “Are you grumpy?” These questions could apply to nearly everyone. Yet, the website will suggest that the test taker should pursue testosterone treatment. This greatly expands their customer base.

Although the recent verdict did not find Abbvie guilty of causing the man’s heart attack, they still have a long, unsound relationship with the FDA. AndroGel was found to increase the chance of heart attack or stroke in their otherwise healthy patients, and they found it doubled the chance in those taking the drug with a heart condition.

These findings are even more startling, given the fact that the effects were studied only three months into therapy. As a result, the FDA ordered Abbvie to place warnings for heart attack and stroke on their label in March, 2015. The manufacturer was urged to put a warning for an increased risk of blood clots after the correlation was found in a study, too.

The recent verdict was issued for what is known as a bellwether trial. This is a trial used to assess the likelihood of the verdict for the class action suit and gives the two sides the option to settle. There are currently 6,000 plaintiffs in the class action consolidated in Chicago. Abbvie will likely appeal the decision, but the verdict should give them a bleak outlook for minimizing exposure in future cases.

In order to control their blood sugar levels, some diabetics use Invokana, the better-known name of the chemical canagliflozin. It is a sodium-glucose cotransporter-2. The drug functions as a cell function inhibitor. To lower the body’s blood sugar levels, Invokana helps the kidneys to reabsorb glucose in the blood stream. It is removed from the body as urine. Although this might sound harmless, Invokana has been linked to many serious health problems. These include:

  • Urinary Tract Infections (UTIs)
  • Renal issues, such as kidney failure and kidney stones
  • Ketoacidosis (acidification of the blood stream)
  • Brittle bones
  • Amputation due to lack of blood flow
  • Heart attack
  • Death

Jansen Health, a subsidiary of Johnson & Johnson, manufactures Invokana, which

really shouldn’t come as any surprise given the substantial continuing legal troubles Johnson & Johnson have found themselves in over the past 18 months.  See here.

Doctors and health officials alike has disavowed Invokana. Dr. Sydney Wolfe testified before Congress about the dangers of Invokana and how its clinical trials were misrepresented in order to gain FDA approval in early 2013. He is the cofounder of the Public Citizen advocacy and lobbying group. The advocates renounced the drug further, calling for it to be pulled from the market in 2015. (Read more about it HERE.) Public Citizen has over 350,000 members nationwide and has successfully gotten additional warnings on drugs or had them pulled from the market due to dangerous side effects.

The FDA and Invokana have a long history together. Since being approved, the FDA has added the following adverse effects to the drug’s label:

  • May 2015: Invokana must warn patients about the increased risk of ketoacidosis on their label. Type 2 diabetics are twice as likely to develop this. It was also given a “black box” label, the most serious warning the FDA can place on a product because of newfound data showing that Invokana increased the risk of limb amputation.
  • September 2015: Invokana must warn patients about the increased risk of bone weakening on their label.
  • December 2015: Invokana must warn patients about the increased risk of UTIs and diabetic ketoacidosis on their label.
  • June 2016: Invokana must warn patients about the increased risk of renal problems, such as kidney stones, on their label.

One can only ask themselves, what’s the next warning on the horizon with this drug?